510(k) · Cleared

Cleared

NHancer Rx

K200324510(k) TraditionalCleared Aug 6, 2020178-day reviewClass II21 CFR 870.1250

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Imds Operations B.V. · DQY Catheter, Percutaneous

Cleared on Aug 6, 2020 as substantially equivalent to K162467 (Vascular Solutions, Inc., 2017) after a 178-day review. Its family tree reaches back 7 generations to 2001. 1 of the 24 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.

Decided: Aug 6, 2020
Review: 178 days
Class: Class II
Product code: DQY
Recalls: None
Predicates: 1

Its longest line of descent runs back 7 generations to K010579 (2001). 22 ancestors in all, the oldest K883718 (1989). 1 later device descends from it, 1 citing it directly. 1 of the 24 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 7 generations backK010579 Stent Support Guide CatheterMedtronic Vascular · 2001 · Recalled
6 generations backK030201 Modification to Export Aspiration CatheterMedtronic Vascular · 2003
5 generations backK040869 Export CatheterMedtronic Vascular · 2004
4 generations backK071727 QXT Extraction CatheterVascular Solutions, Inc. · 2007
3 generations backK072810 Pronto Low Profile (LP) Extraction Catheter, Model 5010Vascular Solutions, Inc. · 2007
2 generations backK083784 Pronto V3 Extraction Center, Model 5003, Pronto LP Extraction…Vascular Solutions, Inc. · 2009
1 generation backK162467 Twin-Pass TorqueVascular Solutions, Inc. · 2017
This deviceK200324 NHancer RxImds Operations B.V. · 2020
Descendant · cites it directly · 0 of its ownK210431 ReCrossImds Operations B.V. · 2021

Class I recalls in this family

K060327 Vascular Solutions Twin-Pass Dual Access…3 generations back · 2006

Most influential descendants

Showing 1 of 1 · See all

K210431ReCrossImds Operations B.V. · 2021 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−7	K010579	Stent Support Guide Catheter	Medtronic Vascular	2001	27
−6	K030201	Modification to Export Aspiration Catheter	Medtronic Vascular	2003	—
−5	K040869	Export Catheter	Medtronic Vascular	2004	—
−4	K071727	QXT Extraction Catheter	Vascular Solutions, Inc.	2007	—
−3	K072810	Pronto Low Profile (LP) Extraction Catheter, Model 5010	Vascular Solutions, Inc.	2007	—
−2	K083784	Pronto V3 Extraction Center, Model 5003, Pronto LP Extraction Catheter, Model…	Vascular Solutions, Inc.	2009	—
−1	K162467	Twin-Pass Torque	Vascular Solutions, Inc.	2017	—
0 (this device)	K200324	NHancer Rx	Imds Operations B.V.	2020	—
+1	K210431	ReCross	Imds Operations B.V.	2021	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0
1993	1	0
2000	1	0
2002	3	0
2003	1	0
2004	1	0
2005	5	0
2006	2	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2021	1	0

FIG. 1 — Lineage of K200324, 2001–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DQY device

#1 K234115 APRO 55 Catheterscore 17.5 · 6 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K162467	Twin-Pass Torque Summary page 4 …ommon/ Usual Name Dual lumen catheter Classification Name Catheter, percutaneous Predicate Device K162467, Twin-Pass torque, dual access catheter, Vascular solutions, Inc.…	Vascular Solutions, Inc.	2017	—
†	K121077	Nhancer	Imds Operations B.V.	2012	—

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K210431	ReCross	Imds Operations B.V.	2021	0

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K060327Vascular Solutions Twin-Pass Dual Access Catheter and Skyway Support CatheterVascular Solutions, Inc. · 2006 · 3 generations back · ◆ in the 2006 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
10 of the 22 ancestors have a recall of any class; 1 has a Class I recall.
Of its descendants, K210431 (Imds Operations B.V., 2021) has gone furthest, with 0 descendants of its own.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.

FDA decisions per year · DQY

21in 2025

2007high 37 (2009) · low 16 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQY

115in 2025

2007high 127 (2014) · low 66 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DQY

1in 2025

2007high 36 (2013) · low 0 (2022)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · DQY

3,056in 2025

2007high 3,190 (2024) · low 313 (2007)2025

MAUDE reports naming product code DQY, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	16	85	6	313
2008	31	66	12	496
2009	37	73	17	819
2010	22	74	32	1,293
2011	36	71	6	1,211
2012	30	87	2	1,191
2013	32	92	36 (1)	1,352
2014	19	127	3	1,497
2015	27	118	3	2,337
2016	22	117	22 (7)	2,252
2017	26	113	8	2,489
2018	25	106	2	2,855
2019	30	111	1	2,902
2020	20	120	2	2,889
2021	18	81	2	3,006
2022	18	74	0	2,643
2023	18	114	17	3,049
2024	16	87	1	3,190
2025	21	115	1 (1)	3,056
2026	11	30	2 (1)	—

What is it indicated for?

The NHancer Rx Dual Lumen Rapid Exchange catheter with hydrophilic coating is intended to support a guide wire during access of coronary and/or peripheral vasculature and allows for exchange of guide wires and provides a conduit for the delivery of diagnostic contrast agents. The catheter is not intended for use in the neurovasculature.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K200324 · printed Nov 6, 2026

Cite this page

510(k) Report. “K200324: NHancer Rx.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200324

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026